Genmab Showcases Data From Robust Development Program Evaluating Epcoritamab (DuoBody®-CD3xCD20) in Patients Across a Broad Range of B-Cell Lymphomas at the 64th Annual ASH Meeting
- Epcoritamab featured in multiple data disclosures, including four oral presentations
- Results presented from the phase 1b/2 EPCORE™ NHL-2 trial of epcoritamab combined with standard salvage therapy in patients with transplant eligible relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL)
- Additional results also presented from the phase 1b/2 EPCORE NHL-2 trial evaluating epcoritamab combined with existing therapies in patients with R/R follicular lymphoma (FL) and previously untreated FL
- Results presented from phase 1b/2 EPCORE CLL-1 trial evaluating epcoritamab in patients with Richter’s Syndrome (RS)
- Additional results also presented from the phase 1/2 EPCORE NHL-1 trial, evaluating epcoritamab in patients with R/R large B-cell lymphoma (LBCL)
“The breadth of clinical data for epcoritamab presented at ASH demonstrates Genmab’s commitment to addressing treatment needs for people living with a variety of B-cell lymphomas,” said Dr.
Notably, results from the phase 1b/2 EPCORE NHL-2 arm (Abstract #443) evaluating 27 patients with R/R DLBCL who were eligible for autologous stem cell transplant, showed an 85 percent (23/27) overall response rate (ORR) and a 67 percent (18/27) complete metabolic response (CMR) rate, following treatment with the combination of subcutaneous epcoritamab plus standard rituximab, dexamethasone, cytarabine, and oxaliplatin or carboplatin (R-DHAX/C) salvage therapy. The most common treatment-emergent adverse events (TEAEs) of any grade were thrombocytopenia (69 percent), anemia (51 percent), neutropenia (44 percent), cytokine release syndrome (CRS) (41 percent), nausea (31 percent), fatigue (28 percent), constipation, diarrhea, headache, pyrexia (all at 24 percent), and increased aspartate aminotransferase (AST) (21 percent). These results were highlighted during an oral presentation on
Results from two additional arms of the EPCORE NHL-2 study, evaluating subcutaneous epcoritamab in combination with rituximab and lenalidomide, one arm in patients with R/R FL and the other arm in previously untreated FL, will be presented during an oral session on
In the R/R FL arm (Abstract #609), 95 percent (63/66) of efficacy evaluable patients treated with subcutaneous epcoritamab in combination with rituximab and lenalidomide achieved an overall response. Among these patients, 80 percent (53/66) achieved a CMR, and 15 percent (10/66) achieved a partial metabolic response (PMR). The majority of patients achieved a response at the first tumor response assessment and most continued to respond through the latest assessment at the time of data collection. The most common TEAEs of any grade were neutropenia (47 percent), CRS (43 percent), injection-site reactions (32 percent), fatigue (31 percent), constipation, COVID-19, pyrexia (all at 25 percent), and infusion-related reaction (21 percent).
In the previously untreated FL patient arm (Abstract #611), 94 percent (34/36) of efficacy evaluable patients who received subcutaneous epcoritamab in combination with rituximab and lenalidomide achieved an overall response, including 86 percent (31/36) achieving a CMR as their best overall response. The most common TEAEs of any grade were CRS (54 percent), neutropenia (47 percent), pyrexia (44 percent), fatigue (37 percent), injection site reaction (37 percent), headache (34 percent), COVID-19 (33 percent), diarrhea (32 percent), constipation (29 percent), rash (27 percent), increased alanine aminotransferase (ALT) (22 percent), and vomiting (22 percent).
Preliminary results from the phase 1b/2 open-label, multi-center safety and efficacy EPCORE CLL-1 trial (Abstract #348) showed that treatment with investigational subcutaneous epcoritamab monotherapy had promising antitumor activity in 10 patients with Richter’s Syndrome, with a 60 percent ORR and a 50 percent CMR rate. Most responses were observed by the first assessment at week six. The most common related TEAEs of any grade percent were CRS (90 percent), anemia (50 percent), neutropenia (50 percent), injection-site reaction (40 percent), thrombocytopenia (40 percent), and hypophosphatemia, hypokalemia, hyperglycemia, COVID-19, diarrhea, fatigue, and nausea (all at 30 percent). These results were highlighted during an oral session on
About Diffuse Large B-cell Lymphoma (DLBCL)
Diffuse large B-cell lymphoma (DLBCL) is a fast-growing type of non-Hodgkin’s lymphoma (NHL) that affects B-cell lymphocytes, a type of white blood cell.1 It is the most common type of NHL worldwide and accounts for approximately 30 percent of all NHL cases.1 DLBCL can arise in lymph nodes, as well as in organs outside of the lymphatic system.1 The disease occurs more commonly in the elderly and is slightly more prevalent in men.1
About Follicular Lymphoma (FL)
Approximately 2.7 per 100,000 people in the
About Richter’s Syndrome (RS)
RS, also known as Richter’s Transformation, is defined as the transformation of chronic lymphocytic leukemia (CLL) into an aggressive lymphoma, most commonly diffuse large B-cell lymphoma (DLBCL).8,9 RS occurs in approximately 2 to 10 percent of CLL patients during the course of their disease.8
About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created using
Epcoritamab is being co-developed by AbbVie and
About
Genmab Forward-Looking Statements
This Media Release contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the
1 Sehn, Salles. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384:842-858. DOI: 10.1056/NEJMra2027612.
2
3 Cancer Stat Facts: Follicular Lymphoma. https://seer.cancer.gov/statfacts/html/follicular.html. Accessed
4 SEER Cancer Statistics. https://seer.cancer.gov/csr/1975_2017/. Table 19.26. Accessed
5
6 Link BK, et al. Second-Line and Subsequent Therapy and Outcomes for Follicular Lymphoma in
7 Ren J, et al. Economic Burden and Treatment Patterns for Patients With Diffuse Large B-Cell Lymphoma and Follicular Lymphoma in the
8 Richter's syndrome.
9
10 Engelberts et al. "DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing." EBioMedicine. 2020;52:102625. DOI: 10.1016/j.ebiom.2019.102625
11 Rafiq, Butchar, Cheney, et al. "Comparative Assessment of Clinically Utilized CD20-Directed Antibodies in Chronic Lymphocytic Leukemia Cells Reveals Divergent NK Cell, Monocyte, and
12 Singh,
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